Antiphospholipid Syndrome (APS) & Finger Stick Machines – Just Say NO!
My Personal Experience with Fingerstick Machines (Home & Clinic) INR Machines
I started this blog entry to help get the word out that home and clinic INR machines are NOT safe to use for patients with Antiphospholipid Syndrome (APS). If you have APS, please read. Thanks.
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Brand of machine that I was using: Roche CoaguChek S
Diagnosis: Seronegative Antiphospholid Syndrome (SNAPS), Lipoprotein (a), Lupus (SLE), Hashimoto’s Thyroiditis
Experience: After much convincing from other APS patients to get this particular machine, I got it. My insurance did not pay for it and since I was told it was basically the next best thing to sliced bread; I paid for it out of my own pocket….close to $2000 USD.
I did many comparisons with the machine before I and my doctor would accept the machine’s numbers. Things were working fine, well past the return date. The periodic comparisons were fine. Almost a year went by with no real problems or at least nothing that caught my attention. However, it was during that time, others who had problems with this machine came to me and gave me in house documents regarding this particular machine.
I was never told that this machine has a standard deviation of 20% +/-. I also found out this particular machine has problems with APS patients.
All the sudden I started having problems. My INR was not matching my symptoms. Well, both my doctor and I assumed my machine was reading right and we would correct the dose. We played this game for a few weeks. I suspected a problem but would check family members who aren’t on warfarin and their INR read right. The controls were fine. It wasn’t until I had another full blown TIA (that I never really recovered from and now years later has been called a stroke) that I realized something was seriously wrong – only this time the machine read 7.0. I checked it again, 7.8. I thought this couldn’t be right; my INR was 2.6 the day before. I checked again, 7.2. I ran all the controls again – both liquid and electronic. Those read fine. Of course, I got freaked and thought this was a bleed. I went to the ER and my INR was really 2.3. Still having the TIA but that machine was really off.
I called the company. They said their machine was fine if the controls were fine but they took the information down to file the incident. We thought that was a fluke. I checked my INR in a few days after an adjusted up. I got a reading of 7.0. I know that wasn’t right. Hospital said it was 4.8. I ordered a new box of strips, more liquid controls and started comparing batch to batch to INR. The batches we matching up but none of it to the lab. The lab readings were were how I was feeling. It got me thinking how long was this machine off a few months ago when we assumed it was right. I was very lucky I didn’t have a full blown stroke because of that machine. It was at that point I stopped using the machine. I just couldn’t trust it any longer.
After about six months, I got my INR back on track by going to the lab once a week. I thought I would spend the money and get a new box of strips since the others were expired and see if this expensive machine would work for me again. I started doing comparisons. The machine was still off. My Factor X matches my INR.
I have smashed the machine into a million pieces and really disgusted at what a waste of money it was. Next time I will do my own research before believing word of mouth, promotion from a group and taking everyone’s experiences into consideration…not just the good ones.
I encourage you to do the same and make an informed decision. Please read the limitation disclaimers for all of the machines on the market before you make your purchase.
Don’t believe what you read here? Call the manufactures of these machines. Yes, despite what you hear on other groups, there is more than one company that makes them. Ask them point blank about the use of these machines with the diagnosis of Antiphospholipid Syndrome (APS).
Lets use some business logic, if the percentage of people having problems were truly so low, they would still try to sell you the machine (they are out to make money – remember), with he “only a few percentage of the APS population has a problem” type of line. They do not say that. They do their best to discourage you from making the purchase one they know you have APS – assuming the vendor / sales rep has ethics. Of course, there are groups that go out of their way to hide the fact these machines have problems with APS patients and have ads & coupons selling these machines. To me, that looks they are making money off the deal. So seriously, as those parties & agencies who are pushing these machines on you, what is in it for them. What out, they tend to be a tad bit paranoid. Do they get kick backs for referrals or own stock in the company? Ask them why they attempt to discredit every negative experience as bunk or urban legend? Or remove it for their sites? As them how they “know it isn’t credible”. It isn’t stirring up drama and making “urban myth”, it is about education. How do they know it hasn’t been reported to the manufacture and the FDA? This is your life and it may be your death that these finger stick machines may cause if you fall into the limitations category. Please report any negative experiences to the company. That is the only way they can try to fix this. Do your comparisons draw regularly. Don’t go with the “well I feel good today and it is in the range where I feel good, it must be ok.” attitude. That is faulty logic. you may not know where your antibodies are going up or down. And please don’t just subtract or add a standard number or the average it has been off. That may not always been that much off – it could be worse that that (or with some luck, better). I have also been reading arguments that errors “…never recommend one of these machines to a person who was permanently positive for LAC as the machine would just not work for them 33% of them (the other 66.6% would still be ok, but the constant worry of the possibility of a false high would be too much to bear”. Who would buy a machine (or any other product for that matter) that may only work 66.6% of the time? Especially when you are not sure what 66.6% the time that is and once again you may not know when your antibodies are going up or down. You may not always be having a “flare”.
Seriously, I have to ask, whit kind of money are these people, groups and organizations making on the promotion of these machines? I mean really, why are they going to APS conferences and standing there promoting these machines? Not a single disclosure made. Why? Please don’t waste your time time messaging me calling me a “fear monger”. I am not. I have cited my sources. It is in black and white from the manufactures. *rolling eyes*
I have been also been reading this is just a “rant”. Funny, it is a CITED rant. You can’t prove it’s safe for Antiphospholipid Syndrome (APS) patients. If you did, you would have those citations out these instead of whining about me. There aren’t any because, the black and white proof is they are NOT. So quit feeding people the bullshit and put your claims that they are safe with citations from the manufactures but I know you can’t because the manufactures can’t even say that.
Happy Reading.
Use these finger stick machines in general at your own risk!
If you don’t have autoimmune problems like APS, these machines may be ok for for you by be fully aware there are problems with these machines (but I am not started to question that as well) and do not let anyone tell you there is not a problem with it comes to APS.
I have collected enough factually supporting information to support my stance. Add in my personal experience and other, well. I still do not understand how groups can refute what the manufactures of these machines say. They really should have a black box warning.
Buyer Beware! Please note, I also have faxes from Roche. If you are interested in them, please contact me. (And a quick shout out to Roche since they seem to be so very interested in my page. Thanks for stopping by, the more you click the higher in the search engines it goes.) Pity, the information came from your company. I am just sharing the truth with the people, that is all.)
Stuck with one of these machines, don’t try selling it on eBay, they will pull it off. They started cracking down on that a long time ago. You need a prescription for it. That is an FDA violation and you could be held liable for any problems the person you sold it to has. In the end, you will end up giving this boat anchor away to destroying it. My suggestion is trying to donate it to a free clinic that could use one and get the tax-write off.
Here were my comparisons. Now there are times that I thought the machine was right and wrote down INR didn’t match symptoms but didn’t go in because a recent comparison was right but now knowing better, chances are it wasn’t right. As fast as it was not working right it is and when do I know when it is isn’t. I supposedly do not have antibodies. Look at the first 10 INRs, they matched. So, I couldn’t return it the machine, it was too late.
Please note: My antibodies were negative the whole time.
INR Comparisons Vein Draw vs Finger Stick. Side By Side
Citations:
Devices for ambulatory and home monitoring of blood pressure, lipids, coagulation, and weight management, part 2
INR Self Testing
INRs from POC instruments are unreliable in about 1/3rd of patients with the clotting disorder called antiphospholipid antibody syndrome (APLA syndrome) who are on warfarin. In these patients, the POC devices give INR readings that are too high, or the instruments report error messages. This is the case with any of the 3 instruments on the market. If you have APLA syndrome, your INRs should be checked from blood drawn from a vein and tested in a laboratory.
http://www.stoptheclot.org/News/article120.htmPatient Variables in PT/INR Testing with INRatio
Questions and Answers: For Use with CoaguChek® Test Strip Urgent Medical Device Correction (UMDC) 06-266 and Urgent Medical Device Recall (UMDR) 06-267
MAUDE Adverse Event Report
Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: early 2007, inratio: 2. 1, lab: 8. 5, mean: 5. 3, confidence limits: unable to be determined. Per internal procedure, the mean of the inratio meter and comparative system inr were calculated. The confidence limits cannot be determined. The readings are considered inaccurate based on “area outside the acceptance region” table. The results are considered discrepant within the context of the documented variability for inr testing. Therefore, further testing is required at this time. In troubleshooting found that the pt has antiphospholipid antibody syndrome. It was explained that possible interferences may be due to the varying levels of the antibodies. Pts condition may cause the discrepant errors.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=992049Antiphospholipid Antibody Syndrome (APS) – NO to Home INR Machines!!
I started this blog to help get the word out that Home INR machines are NOT safe to use for patients with Antiphospholipid Antibody Syndrome. If you have APS, please read! Thanks!
http://apsno2homeinr.blogspot.com/INRatio Monitor and Interfering Substances
Anti-phospholipid antibodies can disrupt the phospholipid in the PT reagent that is necessary for the clotting reaction to occur thus artificially elevating the INR. The APSFA does not promote, sell or make money from this company nor the vendors that sell them. However, if this document has been relocated again, please feel free to contact us for it.
http://www.apsfa.org/docs/HemoSenseTechBull104.pdfThoratec Receives FDA Warning Letter, Plans Recall (ProTime)
Thoratec’s International Technidyne Corp. (ITC) division has received an FDA warning letter citing concerns about its quality systems, specifically those related to certain lots of its ProTime System anticoagulation monitoring device…..of incorrect readings of patient blood coagulation levels.
http://www.fdanews.com/newsletter/article?issueId=10981&articleId=100900
CoaguChek XS System – Patient Experience
Registration Required to read story. “I called Roche and expressed my concerns about the reliability of the machine. They told me that at higher INRs (above 4.0) the machine becomes less reliable. They also told me that the machine doesn’t work very well for people with Antiphospholipid Antibodies because these same antibodies are on the test strips! She said that especially when someone with APS is having a flare up the machine may not work well due to the high level of antibodies in the blood.”
http://health.groups.yahoo.com/group/APLSUK/message/49519i-STAT® PT/INR test
The i-STAT® PT/INR test is a whole blood determination of the prothrombin time used for monitoring oral anticoagulant (warfarin) therapy. The test determines the time required for complete activation of the extrinsic pathway of the coagulation cascade when initiated (activated) with a thromboplastin. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks.
http://www.abbottpointofcare.com/ProTime Systems
Representatives clearly state that this machine has problems with APS patients and patients with the Lupus Anticoagulant. Waiver for patients with APS must be signed. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.
http://www.protimetest.com/CoagCheck Systems
Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. This is for the CoaguChek, CoaguChekS and CoaguCheckXS. Please call technical support at 800-428-4674 for more information. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.
http://www.coaguchek.com/For those inquiring about HOME INR machines…
Registration Required to read this patient experience. “You’re putting your life into a machine that is KNOWN to be wrong with APS patients…think TWICE…THREE times…FOUR times and Just say NO!”
http://www.apsforum.com/forum25/6943.htmlMAUDE Adverse Event Report
Discrepant results (accuracy) comparison of inratio test with lab results provided by end-user at time complaint was filed: date: 01/05/07, inratio: 6. 1, lab: 3. 8, mean: 4. 95, confidence limits: 2. 8-7. 2. Date: 01/15/07, inratio: 4. 3, lab: 2. 8, mean: 3. 55, confidence limits: 2. 2-5. 3. Per internal procedure, the mean of the inratio meter and comparative system inr were calculated. Both inratio and lab values are within the confidence limits for inr testing. The results are not considered discrepant within the context of the documented variability for inr testing. Therefore, further testing is not required at this time. Per text “pt has antiphospholipid antibody syndrome, (cardiolipin-positive, lupus-negative). ” pt’s condition may be causing interference.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=827524INRatio by Alere formerly Hemosense
Validity of Criteria Used to Evaluate Fingerstick Devices That Assess International Normalized Ratio
Medical Decision Making, Vol. 26, No. 3, 239-246 (2006). Conclusion. The unvalidated criteria used to predict warfarin dosing agreement between 2 INR measurements are associated with large error. Warfarin dosing decisions should be measured directly in such assessments.
http://mdm.sagepub.com/cgi/content/abstract/26/3/239MAUDE Adverse Event Report
Caller alleged discrepant results compared with the lab. Results as follows: date: 01/12/07, inratio: 6. 1, lab: 3. 6. Ts updated this case on 01/18/2007 and 01/19/2007. 01/17/07, first test inr = 7. 5(old strip). Second test inr = 5. 5(new strip). Date: 01/19/07, inratio: 6. 5, lab: 4. 0. Caller has antiphospholipid antibody syndrome and recently had an episode of multi organ infection resulting in failure of adrenal glands.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=812419*INR Monitoring in Patients with Antiphospholipid Antibodies with Finger Stick INR Machines.
by: Stephan Moll, MD. A superb way to monitor INRs (International Normalized Ratio) in patients on oral anticoagulants who do NOT have antiphospholipid antibodies (APLA) is though use of “point of care instruments”, where the INR is tested on blood from a finger stick. This method gives fast results and is used by many physicians’ offices and by some patients at home. However, in patients with APLA on oral anticoagulants these instruments may give inaccurate readings.
http://www.apsfa.org/docs/APSFAVol5Spring2007.pdfCoaguChek & CoaguChek S Strip Insert
Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. This is for the CoaguChek & CoaguChekS. Please call technical support at 800-428-4674 for more information. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.
http://www.apsfa.org/docs/Package%20Insert%20for%20CCk%20and%20CCkS.pdfCoaguChekXS Strip Insert
Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. This is for the new CoaguChekXS. Please call technical support at 800-428-4674 for more information. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.
http://www.apsfa.org/docs/XS%20Strip%20Package%20Insert.pdfFactors That Influence INR system Comparisons
Hemochron Jr. Package Insert
Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.
http://www.apsfa.org/docs/FB5933_0307.pdfPoint-of-care testing of the international normalized ratio in patients with antiphospholipid antibodies.
SL Perry, GP Samsa, and TL Ortel Thromb Haemost, December 1, 2005; 94(6): 1196-202. Antiphospholipid antibodies can influence the results of clotting tests in a subset of patients, which can be a major obstacle in monitoring warfarin.The aim was to determine if point-of-care testing of the International Normalized Ratio (INR) is influenced by antiphospholipid antibodies. Please note the manufacture of this machine helped fund this study.
http://www.apsfa.org/docs/ProTime%20and%20APLA.pdfProTime Microcoagulation System Package Insert
Literature clearly states that this machine has problems with APS patient and patients with the Lupus Anticoagulant. Those using this machine should be getting vein draw comparisons at least every 6-8 weeks. The APSFA does not promote, sell or make money from this company nor the vendors that sell them.
http://www.apsfa.org/docs/IR5259_0307.pdfCoagucheck accuracy?
Alere INRatio® PT/INR Test Strips Package Insert
Using Point of Care INR Monitoring
Patient Education Blog | Clot Connect has posted a new item, ‘INR Self-Testing’
INRs from POC instruments are unreliable patients with the clotting disorder called antiphospholipid antibody syndrome (APLA syndrome) who are on warfarin [ref 7]. In these patients, the POC devices give INR readings that are too high, or the instruments report error messages. This is the case with any of the 3 instruments on the market. If you have APLA syndrome, your INRs should be checked from blood drawn from a vein and tested in a laboratory. That value can then be compared to the INR obtained with a POC instrument from a finger stick. Only if both values correlate well may it be acceptable for you to use the POC machine for self-testing.
http://patientblog.clotconnect.org/2012/03/19/inr-self-testing-2/Anti-phospholipid Syndrome and PT/INR
Based on the conclusions of the studies mentioned, different methods of measuring PT/INR behave differently with different APA patients. It is therefore very important to assess the individual patient together with the responsiveness of the PT/INR reagent/system to be used to monitor warfarin therapy (lab or POC). It is also important when performing a correlation study comparing one PT/INR system to another to consider whether any of the patients included in the study have Anti-phospholipid Syndrome. The presence of such samples in the population may affect the correlation.
http://www.apsfa.org/docs/HemoSense%20TechBull108.pdfThe error was discovered because of changes to the reagents — a substance that is mixed with a patient’s blood to do the test. When the region couldn’t get reagent for some aging equipment, senior technologists started to call around to find out how much reagent the rural sites had on hand and the testing error was discovered. About five rural labs need machines replaced. “We’re going to be rethinking our equipment needs in the rural sites as a whole,” Ledingham said. “Whether each of those five individual machines are going to be replaced or perhaps some of them will be serviced from a central site — it will really depends on the needs of the patients and the clinicians in those communities.”
http://www.leaderpost.com/patients+impacted+blood+test+error+Indian+Head+Union+Hospital/6366569/story.htmlFDA Examines Safety of INR Point-of-Care Tests
The FDA convened a panel of experts on Friday to examine the accuracy of point-of-care tests to measure international normalized ratio (INR) in patients taking warfarin, the Wall Street Journal reports.
The agency says such tests have performed poorly in thousands of patients since their approval, with potentially false readings linked to 18 deaths in 2014 and 2015.
Two such tests, INRatio and INRatio2, were withdrawn from the market in 2014 over concerns that they gave faulty readings. INRatio has recently received much attention over its use in the ROCKET AF trial, which led to approval of the anticoagulant rivaroxaban (Xarelto). Critics assert that in ROCKET AF, falsely low INR readings with INRatio would have prompted higher warfarin doses — resulting in higher bleeding risks with the drug and thus making rivaroxaban seem relatively safer. The researchers reanalyzed their data, however, and concluded that the test did not significantly affect the trial’s primary outcomes.
These are Roche’s accepted Standard of Deviations on your readings.
Standard of Deivation Chart from Roche
Again, this is not fearmongering. These are FACTS and this is EDUCATION. I had the machine. I used the machine. Somewhere in this house, I still have the receipt for the purchase of the machine. Saying people postithng that “never used the machines” is a lie. They are posting the true. They are giving your groups FACTS. By removing those facts and this education you are actually doing harm to those posters and you could be held liable. We hope all of you have a very good liablity policy.
“The Claims”
I find it AMAZING when facilites now FLAG APS patients so they do not get a finger stick machine use on them. It is FLAGGED on my chart. There are signs by the finger stick machines themselves as a reminder, at both my hospital and Mayo. This is happening at more and more facilities as more and more awareness is happening or problems are arising.
The FACTS are here. The MAUDE reports speak for themselves. The information from the manufatures speak from themselves. I/we are not in the game of making money off these machines. You safety has and always will come first.
I do have the letter Dr. Hughes gave me convincing me to get the Home INR machine. No where in that letter was there a disclaimer of the issues of this machine or his ties to Roche.
Letter From Roche Diagnotics Stating the Fact about Antiphospholipid Syndrome (APS) and its accuracy.
Letter from Roche Diagnostics
So, yet, with all this evidence, I/we are told we are fearmongering, lying and what not. The evidence is there in black and white. We have nothing to gain from sharing the information and not to lose from hiding the information.
It should be all about PATIENT SAFETY, right?
With that, I am working with the FDA to get a black box warning place on these machines for Antiphospholipid Syndrome.
Edited to add new article on 4/19/2018
Inaccurate Results from INR Meters Prompt New Information from FDA
The U.S. Food and Drug Administration (FDA) has published new information on the agency’s website for people who take warfarin (a blood thinner) and use portable, battery-operated INR test meters to monitor their therapy. This update was prompted by reports that some INR test meters may have generated inaccurate results. The FDA regulates INR test meters and test strips, and the agency wants to make sure all people who use these home-testing devices, regardless of make or model, are using them safely.
https://labtestsonline.org/news/inaccurate-results-inr-meters-prompt-new-information-fda
I found this in a Google search. Amazing, this was not called “fearmongering” but a discussion. I guess it all depends who is saying it. You are being told over and over they are not accurate in Antiphospholipid Syndrome patients expect for a few old doctors at St. Thomas. What does that tell you?!
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